510(k) Report

FDA applicant

Inner Act, LLC

Reno, NV1 decision2004–20040 recalls

FDA records 1 decision for Inner Act, LLC (Reno, NV) in 2004: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Inner Act, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Inner Act, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inner Act, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041103AcneliftInner Act, LLC · 20042cite it

What has FDA decided for it lately?

  • K041103AcneliftInner Act, LLC · 2004

The one decision as Inner Act, LLC →

Other applicant names beginning “Inner”

FDA records each applicant name separately; these may or may not be the same firm.

Inner Mongolia Cureguard Medical Technology Co., Ltd. 3Inner Mongolia Boming Medical Supplies Co., Ltd. 2Inner Vision Biometrics Pty, Ltd. 1Inner Mongolia Cureguard Medical Materials Co., Ltd. 1Inner Vision Mri, Ltd. 1